Overview

Note: Further and more detailed information on the German healthcare market is available in the Commerce’s Global Markets Healthcare Team’s annual Healthcare Technologies Resource Guide.

Germany boasts an exceptional healthcare industry: it allocates the highest share of GDP to healthcare in Europe, ranks in the top ten countries worldwide in healthcare spending per capita, and employs approximately 6.1 million people. Claiming the third-largest medical technology market in the world after the United States and Japan, Germany is by far the largest European market and significantly outperforms continent competitors including the United Kingdom, France and Italy. The German medical device market is one of the largest worldwide, accounting for roughly USD 44 billion (EUR 38 billion) in revenue annually, making up 26.5 percent of the European market.  

Germany has a robust healthcare system, especially with respect to infrastructure, hospital beds and trained staff. One out of six jobs in Germany is linked to the healthcare sector, which generates an annual economic footprint of USD 838 billion (EUR 775 billion), or roughly 12.8 percent of Germany’s GDP. In 2024, the gross value added of the healthcare industry was USD 496 billion (EUR 435 billion). This corresponds to 11.5 percent of the gross value added of the overall German economy. With USD 172 billion (EUR 159.4 billion) generated through foreign sales, healthcare contributed 8.1 percent to Germany’s total exports in 2023. In the same year, healthcare imports were at USD 188.5 billion (EUR 162.7 billion).

Compared to the EU average, Germany has a relatively high number of physicians and nurses. However, 50 percent of physicians are over the age of 50, and the demand for nursing professionals is rising exponentially. Projections indicate that approximately 1.9 million nurses will be needed by 2040, which represents an increase of 300,000 professionals over the current workforce within 15 years. As of April 2025, there was already a shortage of 100,000 nurses.

The medical equipment sector continues to be a pivotal area of trade between the US and Germany. For instance, Siemens Healthineers’ photon-counting CT scanner, the Naeotom Alpha, developed in Germany’s ‘Medical Valley’, has been widely adopted in the U.S., accounting for 40 percent of its exports. In 2023, Germany imported approximately USD 3.17 billion (EUR 2.73 billion) worth of medical instruments and appliances from the United States. This represented approximately 2.09 percent of the global total in this category. At the same time, the value of imports from the U.S. to Germany of the broader category of ‘optical, photo, technical, and medical apparatus’ totaled USD 9.82 billion (EUR 8.4 billion).

The Healthcare/Life Sciences (HCT) industry remains a priority for both the EU and Germany, as reflected in the European Regional Development Fund (ERDF - or EFRE, in German) and the 2021–2027 cohesion policy, as well as through German Länder implementation and tendering of HCT programs. The “Horizon Europe” program, which entered into force in 2021, continues to support health-related R&D with new 2025 calls focused on cancer treatment using generative AI, smart health, aging, and digital models of care. Recent initiatives such as the USD 8.9 million (EUR 7.7 million) EU4MEDTECH project aim to streamline regulatory pathways and boost MedTech innovation. In Germany, major reforms are underway including the 2025 Hospital Reform, the new Medical Research Act introducing confidential drug pricing, and increased federal funding for innovative care models targeting digital health, AI, and underserved health areas. These developments are creating opportunities for U.S. suppliers to participate in healthcare infrastructure and hospital projects and to partner with German and EU firms.     

Market Challenges

Despite progress, due to its decentralized and self-governing structure, the German healthcare system is complex and slow to adapt to new trends. German health ministry officials are committed to modernizing the German healthcare system and have updated the regulatory framework with several laws to drive progress. A significant milestone that is driving digital adoption is the Hospital Future Act, which mandates that hospitals upgrade their information systems by 2027. This deadline prompts healthcare institutions to replace outdated systems with new technologies. The deadline fosters a sense of urgency and provides a clear roadmap for modernization, incentivizing investment in digital solutions that streamline operations, improve patient care, and boost efficiency. This will offer excellent export and partnering opportunities for innovative U.S. healthcare solutions providers throughout the healthcare technologies supply chain. 

Overview of EU Regulatory Framework

The German market for medical devices is regulated by a combination of German and EU directives, standards, and safety regulations. On May 26, 2021, the EU Medical Device Regulation (MDR) replaced the earlier Medical Device Directive (MDD), significantly increasing the requirements for testing, certification, and post-market surveillance. Its complementary regulation, the In Vitro Diagnostic Medical Devices Regulation (IVDR), took effect on May 26, 2022. Unlike EU directives, these regulations are directly applicable in all member states, including Germany.  To address concerns about potential shortages and bottlenecks in certification processes, the European Commission introduced key amendments to the MDR and IVDR in 2023 and 2024. These amendments extend transition periods for “legacy devices” i.e., those certified under the older directives (MDD and IVDD), provided they meet specific conditions, such as maintaining an appropriate quality management system and securing agreements with notified bodies.  Additionally, since January 10, 2025, manufacturers are obligated to inform national competent authorities of anticipated disruptions or discontinuations in the supply of devices that could impact public health. Notifications must be made at least six months in advance to allow healthcare providers and regulatory agencies sufficient time to plan accordingly.

Starting in July 2025, official notices in the EU’s Official Journal (OJEU) will trigger six-month transition periods for each module. The first three modules, (1) actor registration, (2) Unique Device Interpretation (UDI)/device registration, and (3) notified bodies/certificates, are expected to become mandatory by early 2026, with the remaining modules to follow after their audits. Manufacturers must register new devices before market entry post-UDI activation, and legacy devices must be registered within 12 months of the relevant OJEU notice. Notified bodies have 18 months to upload certificates for devices already certified under MDR/IVDR. These changes will require data standardization, early preparation, and close coordination, especially for non-EU manufacturers working with EU representatives. 

Market Challenges

Entry strategies to be considered are top-down or bottom-up marketing, picking the right partners and ensuring patient- and customer-centric system solutions and support. Most medical equipment imported into Germany is either sold directly through a local subsidiary with a field sales force, through medical distributors with an established distribution network (often on a regional/territorial basis), or through appointed agents or manufacturer representatives. Local representation or market presence is essential when considering differing standards and certifications, warehousing costs, maintenance, accessibility, and local marketing, sales preferences, and discussions. An agency agreement is often a cost-effective mechanism to enter the market, but under German law, even if the agent’s performance is not satisfactory, it can be difficult and costly to terminate an exclusive arrangement. A representation or distributorship agreement may be more difficult to arrange, but the German associate will purchase the product and therefore share some market risk. Licensing, partnering with large corporate partners, or buying a local firm provide alternatives in times where traditional distributors are bought up by corporates and the market increasingly consolidates. 

Market Entry Strategy

The German healthcare system is divided into two segments: primary and secondary. The primary market, also known as the SHI market, is funded through statutory health insurance (SHI) and private health insurance (PHI). It is governed by the German Social Security Code, Book V (SGB V). This regulated sector encompasses all essential medical services, long-term care, and rehabilitation. In contrast, the secondary healthcare market is a more liberal, consumer-driven segment. It encompasses privately financed health-related products and services, such as over-the-counter medications, fitness and wellness programs, health tourism, and self-paid individual health services. In contrast to the SHI market, this segment is largely unregulated and shaped by supply and demand. To gain entry to the primary healthcare market, companies and innovators must adhere to a stringent set of regulatory and legal requirements. Compliance with data protection laws, including the General Data Protection Regulation (GDPR), the German Social Security Code (SGB), and the Federal Data Protection Act (BDSG), is mandatory. Furthermore, medical products and services must demonstrate clinical efficacy and benefit through robust, evidence-based studies. This proof must align with the standards of evidence-based medicine (EBM). Moreover, Conformité Européenne (CE) marking is mandatory for all medical devices, as determined by the product’s risk classification under EU regulations. For innovations not seeking reimbursement through SHI, the secondary healthcare market offers a more flexible entry point. In this sector, services and products such as wellness apps, fitness programs, and non-prescription treatments can be marketed directly to consumers, with fewer legal constraints but higher demands for market credibility and consumer trust. The German healthcare system is divided into two segments: primary and secondary. The primary market, also known as the SHI market, is funded through statutory health insurance (SHI) and private health insurance (PHI). It is governed by the German Social Security Code, Book V (SGB V). This regulated sector encompasses all essential medical services, long-term care, and rehabilitation. In contrast, the secondary healthcare market is a more liberal, consumer-driven segment. It encompasses privately financed health-related products and services, such as over-the-counter medications, fitness and wellness programs, health tourism, and self-paid individual health services. In contrast to the SHI market, this segment is largely unregulated and shaped by supply and demand.  

To gain entry to the primary healthcare market, companies and innovators must adhere to a stringent set of regulatory and legal requirements. Compliance with data protection laws, including the General Data Protection Regulation (GDPR), the German Social Security Code (SGB), and the Federal Data Protection Act (BDSG), is mandatory. Furthermore, medical products and services must demonstrate clinical efficacy and benefit through robust, evidence-based studies. This proof must align with the standards of evidence-based medicine (EBM). Moreover, Conformité Européenne (CE) marking is mandatory for all medical devices, as determined by the product’s risk classification under EU regulations.

For innovations not seeking reimbursement through SHI, the secondary healthcare market offers a more flexible entry point. In this sector, services and products such as wellness apps, fitness programs, and non-prescription treatments can be marketed directly to consumers, with fewer legal constraints but higher demands for market credibility and consumer trust. 

Surgical Equipment Market

Overview  

The German surgical equipment market is experiencing steady growth, with a projected compound annual growth rate (CAGR) of 0.85 percent from 2023 to 2030. This growth is largely driven by advancements in robotic and power-assisted systems, as well as other cutting-edge electronic technologies. Surgical instruments, which are designed to cut, remove, or manipulate tissue, have been refined over many years to support surgeons in performing complex procedures. The market is highly competitive, featuring both global and local players. Global companies hold a significant share, while local firms remain active competitors. Germany’s well-developed medical device industry continues to attract international companies seeking expansion opportunities. Key players in the German surgical equipment market include B. Braun SE, Boston Scientific Corporation, Cadence Inc., Conmed Corporation, and Integer Holdings Corporation.  

Leading sub-sectors  

The surgical equipment market is driven by several leading subsectors, each of which contributes significantly to its growth. In terms of products, surgical sutures and staplers have the highest revenue, while electrosurgical devices and powered handheld instruments, such as drills and staplers, are experiencing the fastest growth due to their use in minimally invasive and orthopedic procedures. Application-based subsectors such as obstetrics and gynecology and plastic surgery are demonstrating robust growth, with neurosurgery and orthopedics also gaining traction. Specialty segments such as operating-room (OR) equipment, including tables and lighting, and surgical robot accessories are experiencing significant growth, particularly in Germany. The market is further fueled by trends in robotic-assisted surgery, AI integration, and the shift toward minimally invasive techniques. Europe’s surgical equipment market is expected to grow at a CAGR of 8.7 percent through 2030.

Opportunities  

Germany’s surgical equipment market offers significant opportunities, largely driven by its strong focus on quality, patient safety, and world-class research and development. The country’s rigorous quality standards, enforced by bodies like the Joint Federal Committee (G-BA) and the German Institute for Medical Documentation and Information (DIMDI), ensure widespread adoption of advanced, high-precision surgical technologies that meet EU safety requirements, including the mandatory CE certification. This regulatory focus, while strict, also positions Germany as a global benchmark for medical device quality. The company’s robust R&D ecosystem, supported by renowned academic institutions and government entities such as the Federal Ministry of Research, Technology and Space (BMBF), which funds advancements in surgical techniques, materials, and robotic-assisted systems, is a key driver of its growth potential. These strategic partnerships drive ongoing innovation, leading to the development of advanced technologies that improve surgical precision and patient outcomes. While regulatory compliance under the EU MDR presents challenges, the robust R&D foundation and institutional collaboration offer substantial long-term opportunities for innovation, investment, and market expansion in the German surgical equipment sector. 

Single-Use Medical Devices

Overview  

The single-use medical devices sector in Germany is a rapidly expanding segment within the broader healthcare market. This growth is driven by the increasing demand for infection control, convenience, and efficiency in clinical settings. This category includes disposable products such as syringes, catheters, gloves, gowns, and sterile procedural tools. These products are essential for minimizing healthcare-associated infections and streamlining medical procedures. In 2023, the German market for medical disposables was valued at approximately USD 18.6 billion (EUR 16 billion) and is projected to grow significantly, reaching USD 53.4 billion (EUR 46 billion) by 2030, with a strong CAGR of 16.3 percent. Key sub-segments, such as disposable and prefilled syringes, are also experiencing double-digit growth, reflecting increasing number of medical procedures and demand for ready-to-use solutions. Germany’s well-developed healthcare infrastructure and aging population will help drive ongoing demand for these devices. While the market remains attractive, it is also influenced by evolving regulatory frameworks under the EU MDR, including provisions for the reprocessing of certain single-use items. Furthermore, environmental concerns are prompting the industry to adopt more sustainable and eco-friendly disposable solutions. Germany offers a highly favorable environment for innovation and investment in single-use medical technologies.

Leading sub-sectors  

As mentioned, Germany’s single-use medical device market is led by disposable syringes, which generated USD 432.4 million (EUR 372 million) in 2023 and are projected to reach USD 1 billion (EUR 861.4 million) by 2030, with a CAGR of 13.2 percent. Prefilled syringes also play a key role, with revenues of USD 480.8 million (EUR 414.1 million) in 2024, expected to climb to USD 1.04 billion (EUR 895.8 million) by 2030 (CAGR 14.1 percent). Disposable catheters, particularly cardiovascular models, generated USD 2.96 billion (EUR 2.55 billion) in 2022 and are projected to reach USD billion 4.86 (EUR 4.2 billion) by 2030 (CAGR 6.4 percent), while suction catheters increased from USD million 23.8 in 2022 to a forecasted USD 52.7 million (EUR 45.4 million) by 2030 (CAGR 10.5 percent). Beyond these items, medical gloves, surgical masks, gowns, drapes, IV tubing, infusion sets, laboratory and diagnostic disposables, and pre-packaged surgical procedure kits play essential roles. These items are sustained by Germany’s strict infection control standards, robust hospital infrastructure, and growing procedural volumes.  

Opportunities  

Germany presents strong and diverse opportunities for U.S. companies entering the single-use medical device market. These opportunities are supported by Germany’s reputation for high-quality healthcare, strong R&D focus, and a well-established regulatory system. Demand is driven by the need for infection control, operational efficiency, and hygienic care across hospitals, outpatient facilities, and home healthcare. U.S. firms can benefit from Germany’s broad market segments, including sterilization supplies, disposable drug delivery products (e.g., pre-filled syringes, inhalers), non-woven disposables, wound care items, and incontinence products. The market is experiencing growth due to the aging population, rising healthcare costs, and increasing procedural volumes. Additionally, Germany’s rigorous yet transparent regulatory framework, overseen by the Federal Institute for Drugs and Medical Devices (BfArM) and Paul Ehrlich Institute (PEI), ensures consistent quality and safety standards, creating a competitive yet accessible pathway for compliant U.S. exports. Key advantages include opportunities to supply specialized materials (such as high-grade plastics, rubbers, and non-wovens), meet growing demand in home care, and align with emerging sustainability trends by offering eco-friendly, single-use innovations. 

Electromechanical Medical Devices

Overview

Electromechanical medical devices combine mechanical systems with electronic controls to perform critical diagnostic, monitoring or therapeutic functions. There are many applications for electromechanical medical devices in the healthcare industry, for example as precise drug delivery systems. German giants including Fresenius SE & Co. KGaA, Draegerwerk AG & Co. KGaA and Paul Hartmann AG produce cutting edge medical technology ranging from dialysis machines to blood pressure monitors. Close collaboration between manufacturers and university hospitals, a strong pool of engineers and an innovative MedTech industry have benefited the sector.  

Leading Sub-Sectors

Leading electromechanical medical device sub-sectors include diagnostic imaging equipment such as MRI, CT or X-ray scans, electrosurgical and monitoring devices such as EKGs, active implantable devices such as pacemakers, respiratory systems including ventilators and anesthesia machines and surgical robotics such as robotic arms.  

Opportunities

Opportunities to break into the German electromechanical medical device market are plentiful. For one, the country’s aging population means there is increasing demand for active implantable and monitoring devices. Moreover, there has been a significant push to embrace digital health reforms, financially supported by federal government stipends. Finally, in line with the EU MDR regulations, innovative, compliant electrotechnical devices are in high demand.  

Market Challenges

The electromechanical medical device market in Germany is highly advanced but faces various sorts of challenges ranging from strict regulatory compliance under the EU Medical Device Regulation (MDR, 2017/745) to pressures from hospitals operating within a growing staffing deficit. Particularly Small and Medium Sized Enterprises (SMEs) are especially affected by bureaucracy, facing exorbitant cost and time increases in putting their goods on the market. Compliance with EU ‘notified bodies’ presents another time-consuming obstacle. 

Diagnostic Devices

Overview  

Germany is Europe’s largest medical device market and a global leader in clinical diagnostics. The diagnostic devices sector is growing rapidly, with particular strength in the areas of in vitro diagnostics (IVD), point-of-care (POC) testing, and laboratory instruments. In 2024, the IVD market alone was valued at approximately USD 8 billion (EUR 7 billion) and is projected to exceed USD 11.5 billion (EUR 10.06 billion) by 2030. Germany’s aging population, rising chronic disease rates, robust healthcare infrastructure, and increasing adoption of digital and personalized medicine are driving this growth. A well-developed network of clinical laboratories established reimbursement systems, and regulatory alignment with EU standards (under IVDR) further support sector expansion.

Leading Sub-Sectors

The IVD segment is the dominant player in the market, with infectious disease diagnostics, immunochemistry, and clinical chemistry representing the largest revenue categories. POC diagnostics are gaining significant traction, particularly for chronic conditions and in decentralized care settings. Germany now accounts for around 15 percent of the Europe, Middle East, and Africa (EMEA) POC market. Laboratory instruments are also in high demand, driven by the need for automation, digitization, and high-throughput systems. The country is home to major global players such as Roche Diagnostics, Siemens Healthineers, and Abbott, as well as innovative SMEs specializing in instruments, software, and reagents.

Opportunities

U.S. companies have a strong opportunity to enter or expand in Germany’s diagnostic sector, especially with high-quality, FDA- and CE-marked products. There is robust demand for AI-enabled diagnostic tools, molecular and genetic testing platforms, rapid POC solutions, and integrated lab automation systems. The country’s emphasis on precision, innovation, and compliance aligns well with the strengths of U.S. firms. Success in this market will depend on regulatory readiness (particularly IVDR), local distribution or integration partnerships, and visibility at trade events like MEDICA. With the right strategy, Germany can serve as both a lucrative market and a launchpad into the broader EU diagnostics landscape. 

Medical Technologies

Overview

Medical Technologies are the key sector of the healthcare industry. After the European Union, the United States ranks second as Germany’s largest import source for medical devices. Germany has demonstrated leadership in innovation, with 1,380 MedTech patents registered in 2023 and investments exceeding USD 3.4 billion (EUR 3 billion) in R&D. The German medical technology industry is a significant player in the global economy, with 13,500 manufacturers and over 265,000 employees contributing to a total revenue of USD 63.8 billion (EUR 55 billion). Exports play a vital role, with over two-thirds of revenues from larger firms earned internationally, primarily within Europe, though the U.S. and China remain key markets.

Market challenges  

Germany’s reputation for extensive and expanding regulatory requirements applies to the medical technology industry as well. The German Act on Corporate Due Diligence Obligations in Supply Chains and the EU’s new Health Technology Assessment Regulation, for example, introduce additional administrative and cost burdens. Moreover, the proposed broad restriction of perfluorinated and polyfluorinated alkyl substances (PFAS) by the European Chemicals Agency could disrupt critical chemical supply chains that support MedTech manufacturing in Germany.

Digital Trade Opportunities  

Germany’s medical technology industry offers significant growth prospects across multiple key sectors. The medical aids sector, which includes devices such as prostheses, wheelchairs, and hearing aids, experienced a 7.4 percent increase in spending, reaching USD 26.6 billion (EUR 23.2 billion) in 2023. This growth can be attributed to an aging, and thus increasingly care-dependent, population, which is projected to exceed 5.5 million by 2050. In the field of digital health, Germany’s Digital Care Act has facilitated the widespread adoption of reimbursable digital health applications, referred to as “DiGAs.” As of 2023, the act has approved 56 such applications, generating over USD 86 million (EUR 75 million) in revenue, with a particular focus on addressing psychological and metabolic conditions. Meanwhile, the in vitro diagnostics (IVD) market, the fourth largest globally and accounting for 30.3 percent of the European market, is set to grow by 3.2 percent annually through 2029, fueled by demographic changes, chronic disease prevalence, and advancements in digitization, AI, and robotics that are transforming diagnostics and personalized care. 
Resources

Trade Events

• Analytica, Munich, March 24-27, 2026
• International Dental Show (IDS), Cologne, March 25-29, 2026
• DMEA (Digital Health), Berlin, April 21-23, 2026
• American Hospital Association Leadership Summit, Nashville, TN, July 12-14, 2026
• American Assoc. for Clinical Chemistry: AACC Annual Meeting, Chicago, July 26-30, 2026
• Expopharm, Munich, September 16-18, 2025
• Rehacare, Düsseldorf, September 17-20, 2025
• Medica, Düsseldorf, November 16-17, 2026  
• Compamed, Düsseldorf, November 16-17, 2026 (held in tandem with Medica at Messe Düsseldorf) 

Local Medical Industry Associations

BVMED

ZVEI Health Pages

Spectaris

DKGEV

BVITG

Government Links

Federal Ministry of Health

Federal Ministry of Education and Research  

Federal Institute for Drugs and Medical Devices (Competent Authority)  

Healthcare Procurement and Tenders (Federal Portal)  

Government Health Plans

International Federation of Health Plans

Association of Public Health Plan Providers